ML20244E557
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,of\ , )og UNITED STATES /' Y p )y - g NUCLEAR REGULATORY COMMISSION WASWNGTON, D. C. 20556 g ;p g January 9,1987 MEMORANDUM FOR: John G. Davis, Director Office of Nuclear Material Safety and Safeguards FROM: James M. Taylor, Director Office of Inspection and Enforcement
SUBJECT:
ORAFT COMMISSION PAPER: QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE (MEDICAL PROGRAMS)
We have reviewed the draft Commission paper and have provided comments as an enclosure. Our major comments are as follows:
- 1. The draft Commission paper, page 4, first full paragraph indicates a need to modify the Enforcement Policy. We do not believe a modification
! is needed because Supplement VI, Severity Level III, line 6, " therapy misadministration" would be applicable for failure to follow quality assurance procedures. It is used now for failure to follow procedures or failure to report therapy misadministration. Severity 1.evel III l infractions usually result in a civil penalty. Therefore, references
! to modification to the Enforcement Policy should be deleted throughout the package.
- 2. The draft Commission paper, page 6, first paragraph, first partial sentence is not entirely correct. The second line should read "... once each two or three years, depending on whether it is a broad license (every 2 years) or group license (every 3 years)." The first full sentence is not true and should be deleted. Further, the second full sentence that states: "An increased NRC presence may improve ... and lead to a reduction in the misadministration rate." is not necessarily true. The licensee has a responsibility to follow the rules. More frequent inspections will not necessarily improve licensee performance.
A quality assurance program probably will. We suggest the sentence also be eliminated.
- 3. Enclosure 2, page 9, third sentence states (for teletherapy) that the independent check be made before 20 percent of the dose has been administered. We emphatically believe the calculation of the dose must be made before any treatment begins unless there is a medical necessity.
- 4. Enclosure 2 contains elements that would logically be made part of a quality assurance program, the purpose of which is to prevent misadmin-istrations. However, nowhere in either the immediately effective rule or the advanced notice for the full rulemaking is there a basic require- I ment that licensees have a quality assurance plan. We believe that it i is important to require the licensee to have their own identifiable quality assurance plan containing the important elements and tailored to the particular licensees' operatiors. We request that such a require-l ment be added in the advanced notice of proposed rulemaking. The licensee's document will then form the basis upon which NRC can inspect l
licensee operations to verify compliance. The inconsistency between the ,
Commission paper and the final rule should also be resolved.
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John G. Davis .- ' Enclosure 2, page 17, S35.302 should read: "In addition to the require-ments in S35.53, a licensee shall verify that the prescribed radio-pharmaceutical is being administered as follows:
(1) compare the written prescription with the information on the container label (2) calculate therapeutic dosages prior to calibration of dosages (3) screening and approval by the authorized users or a physician
. working under the supervision of the authorized user of all procedures I that require administration of therapeutic quantities of I-131, I-123, P-32, or administration of diagnostic quantities of such radiopharma-ceuticals that may result in therapeutic doses to patients."
- 6. Enclosure 4, page 2, Item 3, third paragraph states that some Agreement States do not have QA requirements and that we might be inconsistent with this. We fail to see the logic in that paragraph and request that it be deleted.
- 7. 10 CFR 35 specifies training requirements.for physicians and radiation safety. officers but does not currently include any requirements for training and certification of nuclear medicine technologists, who in most cases are the people who perform most of the functions involved with administering radiation or radiopharmaceuticals to patients. IE believes that NRC should consider, as part of the ANPR'to prevent medical misadministration, requirements on~ training, qualification and certification of nuclear medicine technologists, and request comments from the public, the medical practitioners, and professional groups. It is suggested that the response to the Commission question 3 on training be revised to state that this is an'important area which will be considered during the full rulemaking initiated by the ANPR.
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mes M. Taylor Director ffice of Insp ction and Enforcement i i
Enclosure:
Comments cc w/ enclosure:
R. Cunningham, NMSS N. McElroy, NMSS
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- 1. Enclosure 1, page 1. In the middle of the
SUMMARY
paragraph we suggest the wording be changed to read "... would also provide penalties for ,) V f[fhY misadministration caused by failure to follow quality assurance programs , / 7 7 when using byproduct material for radiation therapy." ' y e' o
- 2. Enclosure 2, page 9. Second paragraph, first sentence states, ".... .
calculations should be checked." This should be a requirement. U Z
G Same, penultimate paragraph. Add to last sentence, "... by two independent oj9' ~
calculations."
Same, last paragraph, last sentence. The alternative presented would ,' j ,d'b' j
not really be an independent check even though it states that the 'd i alternative is one of two usual methods. What is usual in the industry may not be appropriate. "
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- 3. Enclosure 2, page 16. Insert a definition of " independent calculation." ,,[
- 4. Same third paragraph. It should be clear as to whether the definition f refers to the teletherapy chart, brachytherapy chart, or the general chart @'
which contains all the patient information from admission to the time the .,,
patient leaves the hospital. . .g
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- 5. Enclosure 2, page 17, section (d). This. regulation may not be enforceable y ); ,4 ,g as written. Even if the licensee does its job, instruction orally and in 4 writing to technologists, it would be difficult to enforce this rule, The technologist may not request clarification because he/she believ f '7) >
the orders are clear - even if they are not.
preted in many ways. The only alternative would be i.o have every techno-Wm ") yl*t i logist have every order clarified or to delete the rule. U + q ' J N" d 9 - ' ' !
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- 9. Enclosure 2,page10,s35.454(a),(b),and(c). These paragri'phs do not (b {
For para-clearly graph (a) indicate a requirement thut the checks be independent.we y[;
suggest the who did not make the original calculations." We suggest the same change e forparagraph(b). For paragraph (c), page 19, we propose, "... in order 'd to perform an independent check ... performing the independent check.
The licensee shall perform the confirmatory checks ...." gh. ./
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- 7. Enclosure 2, page 20, 535.654(a) and (b). Again, (a) should read
... for accuracy by a second individual ...", and (b) "The check must g)"j g
be made by an individual who did not enter the original ...." 4 {t % cp
- yy Same,(d),thirdline "
... physical measurement ..." Define the term. O,fi<G <:
y Same, paragraph (e ), should read "... in order to perform an independent 9; check." 'O ( (,
Same, page 21, top line, should read " performing an independent check ...." U m .n!
- 8. Enclosure 3, page 3, second paragraph. "... (each two or three years, but usually achieved ...).
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- 9. Enclosure 3, page 5, first paragraph "NRC presence is not very great Ojd'__./,
in nuclear medicine." See comment No. 2 of the cover letter.
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"p Same, last sentence. We disagree that more frequent inspections wculd )/
reduce misadministration (see comment No. 2 of cover lctter). <o :[j
- 10. Enclosure 3, page 6. first paragraph. " Recommendation." We don't believe "g r
't necessary to have a contract for a study about the patterns of j technologists duties. We are already aware of the dutier of the techno-icgists. IE and regional staff could probably put together an adequate
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or better study than a contractor. However, there could well be a useful study of some kind on the radiation protection problems related to future medical uses of radioisotopes in medicine.
i II. Enclosure 3, No mention is made of Information ,
Hotices (ins)page 8, Response issued 8. to Question 8.
by IE related We suggest listing the following pertinent ones. /
Information Notice No. Title i 86-85 Enforcement Actions Against Medical Liccnsees for Wilfull Failure to Report Misadministration 86-84 Rupture of a Nominal 40-millicurie Iodine-125 Brachytherapy Seed Causing Significant Spread of Radioactive Contamination 86-04 Defective Teletherapy Timer that May Not (Bulletin) Terminate Treatment Dose 86-95 Leak Testing Iodine-125 Sealed Sources in Lixi, Inc. Imaging Devices and Bone Mineral Analyzers 85-61 Misadministration to Patients Undergoing Thyroid Scans 84-85 Molybdenum Breakthrough from Technetium-99m Generators 84-62 Therapy Misadministration to Patients !
Undergoing Cobalt-60 Teletherapy Treatments aj
- 12. Enclosure 4, page 1, Item 2, " Operator Error." What does this have to jf/
do with QA at hospitals? Individuals at hospitals are not licensed; y' w reactor operators are. If they make a mistake, NRC suspends their license.
We cannot do that with hospital employen . This paragraph should be ,aA/ A/r reconsidered and rewritten.
- 13. Enclosure 4, page 3, Item 8. Inspections are a random sampling of records, . s' l interviews with personnel, among other things. The inspector's job would !i be primarily to determine if the licensee had a QA program as required and if the licensee was implementing that program and to check to see if hN
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independent verifications were done. They would not have to perform any j more calculations than they do now. l
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- 14. Commission letter, page 8, concurrence. R. C. DeYoung is no longer /./ ' 2
'1, with IE; he is retired. G..H. Cunningham is no longer in ELD, & J
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- t l 15. Enclosure 1, page 5 first: Nil paragraph. Stateregulator,0 agencies
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l are asked to comment. / ,,
,",f l 16. Enclosure 2, page 6, second paragraph. This paragraph describes wha a 1
' ," h Y' I patient's chart contains. Os this a requirement e is it expectedt .lt s .
is not clear. ( ,
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- 17. Enclosure 2, page 7. The first line on the page states that the NRC ;
l considered prescriptive recordkeeping requirements. Where was this considered? At the end of the first paragraph it states, "There would O>Vf7 '
fP be no benefit gained by imposing recordkeeping requirements." It is .< not, ? ",. ,
clear why this should be stated here. - . V V}~ O f Same, seconf paragraph, third etence. Are we requiring this? It is ya ,+
<not clear. <
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, , i , av Same, here about third parag"raph, instructing udrkers to laktkrequest sentence'.
clarification. , There It seems seems that to be swie f licenees need to have QA procedures that clearly spell out all of the ;4 v, /
aspcts of the program desigyW to ensure that therapy is carried out Yo in accordance with written prescriptions, f
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- 18. Enclosure 2:, page 10, first paragraph, first lin'e. ~ The term " arithmetic" ,
seems too nn.ple. Do you mean " calculations"? Also, third line regarding , f,',
a weekly check. Why is this frequency specified? Is it going to be a W o5 reaufrement? 4
- .< ' . 1 > ,m a .m ; W;. s Sake. Necodd paragraph > first sentence.seads, ". . . the beam collimators,' '.
and the retient was reghtred." WrNf/ prd? m - w / r - d ,L
- 19. Enclosure 2, page 16, definitions. In the fourth paragraph should the j -
term written prescriptions be useii? In the fifth paragraph " Roentgens" d shoulo not be capitalized, y Same,'sicMan 35.43. In the phrase "... if there is a primary care ,a b
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physician . . . . " Doesn't there have to be? ,.y
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- 20. Enclos'ure 2, page 17(b)., second line shcmld read. >
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- ill out, date ...." r. ,..,
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Same. IniAems(1),(2),and(3)theterm"also" appears,butinadditionj" to what else? Or shouhi the term %e struck? For items (1), (2), and (3)
M or ldn't we say _" written, prescription." For item (1), such prescription , ,
- is> fritten on a consult orf requisition instead of the patient's chart. G l , , ., Li
! Lame,735.43(d),firstline. Change "wnrkers" to read "perscnnel involved l ir, the administration off tbe prescribed dose.,"
, ;< i Same, $35.432, secono sentence, should renj, " Sources ... in., storage and not be,ina used heve to be measured before ...".
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